Last week, President Biden signed a broad executive order with the stated intent of “promoting competition” in the economy. The order touched on several industries, including agriculture, Internet services, banking and healthcare. As is the case with almost all executive orders, this does not immediately enact any changes, but rather directs the pertinent agencies to focus on, and in certain cases begin rulemaking in, these areas.

The order directs relevant federal antitrust agencies to crack down on consolidation in several areas, including hospital consolidation and consolidation within the prescription-drug sphere. “Hospital consolidation has left many areas, particularly rural communities, with inadequate or more expensive healthcare options,” the order states. “And too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” The latter half of this statement refers to “pay-for-delay” deals, when one pharmaceutical manufacturer pays another to delay the rollout of a competitive drug. NAHU has submitted testimony to Congress advocating for the end of pay-for-delay deals. The executive order also deals with consolidation in health insurance, specifically regarding carriers in the marketplace. The order directs HHS to standardize plan options in the National Health Insurance Marketplace so people can comparison-shop more easily.

In addition to hospital consolidation, the order directs HHS to support existing hospital price transparency rules and to finish implementing bipartisan federal legislation to address surprise billing in the hospital setting. The price transparency rule that this order refers to is the Trump-erahospital price transparency final rule that went into effect on January 1, which requires hospitals to make public “a machine-readable file containing a list of all standard charges for all items and services” as part of an initiative to empower patients through more accessible healthcare information. Regarding surprise billing, “Part 1” of the implementation that this order refers to was recently released; however, several more rules will be released in the coming months, including those specific to the hospital setting.

In addition to these items, the executive order outlines how expensive hearing aids can be for many Americans, and directs HHS to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter. “A major driver of the expense is that consumers must get them from a doctor or a specialist, even though experts agree that medical evaluation is not necessary,” the order notes. “Rather, this requirement serves only as red tape and a barrier to more companies selling hearing aids.”

Regarding prescription-drug prices, on top of directing agencies to end pay-for-delay deals, this executive order directs the FDA to work with states and tribes to safely import prescription drugs from Canada, pursuant to the Medicare Modernization Act of 2003. The Medicare Modernization Act allows U.S. wholesalers and pharmacists to legally import drugs from Canada, provided that HHS authorizes it. The Biden administration recently filed a motion in federal court seeking to dismiss a lawsuit against drug importation brought by pharmaceutical associations. Finally, this executive order directs HHS to issue a comprehensive plan within 45 days to combat high prescription drug prices and price gouging, including the enhancement of domestic pharmaceutical supply chains.

NAHU will be submitting comments on any proposed rules that are relevant to our industry released as a result of this executive order.